NL-OMON54015尚未招募3 期
An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) - ASSERT-EXT
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Albireo AB
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
入选标准
- •1. Completion of the 24-week Treatment Period of Study A4250-012;
- •2. Signed informed consent and assent as appropriate. Patients who turn 18
- •years of age (or legal age per country) during the study will be required to
- •re-consent to remain on the study;
- •3. Caregivers (and age-appropriate patients) must be willing and able to use an
- •electronic diary (eDiary) device as required by the study;
- •4. Sexually active males and females must agree to use a reliable contraceptive
- •method with <= 1% failure rate (such as intra-uterine device, or complete
- •abstinence) from signed informed consent through 90 days after last dose of
- •study drug;
排除标准
- •1. Decompensated liver disease, history or presence of clinically significant
- •ascites, variceal hemorrhage, and/or encephalopathy;
- •2. Patients who were not compliant with study drug treatment or procedures in
- •Study A4250-012;
- •3. Any other conditions or abnormalities which, in the opinion of the
- •investigator, may compromise the safety of the patient, or interfere with the
- •patient participating in or completing the study;
- •4. Known hypersensitivity to any components of odevixibat;
研究者
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